37496 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Rules and Regulations 

(1) For any airplane that has had a wing 

removed and reinstalled or replaced between 

June 2007 and July 15, 2016 (the effective 

date of this AD): Within the next 12 months 

after July 15, 2016 (the effective date of this 

AD), inspect the torlon plates in the forward 

lower wing-to-fuselage attachments (both left 

hand (LH) and right hand (RH) sides) for 

correct installation following the 

accomplishment instructions in PILATUS 

AIRCRAFT LTD. PC–12 Service Bulletin No: 

57–007, dated September 29, 2015. 

(2) For any airplane that has had a wing 

removed and reinstalled or replaced, between 

June 2007 and July 15, 2016 (the effective 

date of this AD): If an incorrect installation 

of the torlon plates is found during the 

inspection required in paragraph (f)(1) of this 

AD, remove the affected torlon plates, 

visually inspect the torlon plates and the 

affected lugs using a mirror and light source 

(if necessary) for any damage, and reinstall 

the torlon plates in the correct sequence, 

following the accomplishment instructions in 

paragraph 3.C. of PILATUS AIRCRAFT LTD. 

PC–12 Service Bulletin No: 57–007, dated 

September 29, 2015. 

(3) For any airplane that has had a wing 

removed and reinstalled or replaced, between 

June 2007 and July 15, 2016 (the effective 

date of this AD): If any damage is found 

during the inspection of the torlon plates and 

lugs required in paragraph (f)(2) of this AD, 

before further flight, contact PILATUS 

AIRCRAFT LTD. for FAA-approved repair 

instructions and accomplish those 

instructions accordingly. You may find 

contact information for PILATUS AIRCRAFT 

LTD. in paragraph (h) of this AD. 

(4) For all airplanes: As of July 15, 2016 

(the effective date of this AD), do not install 

or re-install a wing on any airplane, unless 

concurrent with the wing installation, the 

torlon plates of the forward lower wing-tofuselage attachment (both LH and RH sides) 

of the airplane are inspected and found to be 

installed correctly in accordance with the 

accomplishment instructions in paragraph 

3.B. of PILATUS AIRCRAFT LTD. PC–12 

Service Bulletin No: 57–007, dated 

September 29, 2015. 

Note 2 to paragraph (f)(4) of this AD: 

Installation of a wing on an airplane in 

accordance with the instructions of PILATUS 

aircraft maintenance manual (AMM) 02049, 

Revision 28 or later, or AMM 02300, Revision 

11 or later, is an acceptable alternative 

method to comply with this inspection 

requirement. 

(g) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, Standards Office, 

FAA, has the authority to approve AMOCs 

for this AD, if requested using the procedures 

found in 14 CFR 39.19. Send information to 

ATTN: Doug Rudolph, Aerospace Engineer, 

FAA, Small Airplane Directorate, 901 Locust, 

Room 301, Kansas City, Missouri 64106; 

telephone: (816) 329–4059; fax: (816) 329– 

4090; email: doug.rudolph@faa.gov. Before 

using any approved AMOC on any airplane 

to which the AMOC applies, notify your 

appropriate principal inspector (PI) in the 

FAA Flight Standards District Office (FSDO), 

or lacking a PI, your local FSDO. 

(2) Airworthy Product: For any requirement 

in this AD to obtain corrective actions from 

a manufacturer or other source, use these 

actions if they are FAA-approved. Corrective 

actions are considered FAA-approved if they 

are approved by the State of Design Authority 

(or their delegated agent). You are required 

to assure the product is airworthy before it 

is returned to service. 

(3) Reporting Requirements: For any 

reporting requirement in this AD, a federal 

agency may not conduct or sponsor, and a 

person is not required to respond to, nor 

shall a person be subject to a penalty for 

failure to comply with a collection of 

information subject to the requirements of 

the Paperwork Reduction Act unless that 

collection of information displays a current 

valid OMB Control Number. The OMB 

Control Number for this information 

collection is 2120–0056. Public reporting for 

this collection of information is estimated to 

be approximately 5 minutes per response, 

including the time for reviewing instructions, 

completing and reviewing the collection of 

information. All responses to this collection 

of information are mandatory. Comments 

concerning the accuracy of this burden and 

suggestions for reducing the burden should 

be directed to the FAA at: 800 Independence 

Ave. SW., Washington, DC 20591, Attn: 

Information Collection Clearance Officer, 

AES–200. 

(h) Related Information 

Refer to MCAI European Aviation Safety 

Agency (EASA) AD No.: 2016–0037, dated 

February 26, 2016, for related information. 

The MCAI can be found in the AD docket on 

the Internet at: https://www.regulations.gov/

#!documentDetail;D=FAA-2016-5284-0002. 

(i) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless the AD specifies otherwise. 

(i) PILATUS AIRCRAFT LTD. PC–12 

Service Bulletin No: 57–007, dated 

September 29, 2015. 

(ii) Reserved. 

(3) For PILATUS AIRCRAFT LTD. service 

information identified in this AD, contact 

PILATUS AIRCRAFT LTD., Customer 

Support Manager, CH–6371 STANS, 

Switzerland; phone: +41 (0)41 619 33 33; fax: 

+41 (0)41 619 73 11; email: SupportPC12@

pilatus-aircraft.com; Internet: http://

www.pilatus-aircraft.com. 

(4) You may view this service information 

at the FAA, Small Airplane Directorate, 901 

Locust, Kansas City, Missouri 64106. For 

information on the availability of this 

material at the FAA, call (816) 329–4148. In 

addition, you can access this service 

information on the Internet at http://

www.regulations.gov by searching for and 

locating Docket No. FAA–2016–5284. 

(5) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, call 

202–741–6030, or go to: http://

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued in Kansas City, Missouri, on June 1, 

2016. 

Pat Mullen, 

Acting Manager, Small Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2016–13372 Filed 6–9–16; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2016–4878; Directorate 

Identifier 2016–CE–001–AD; Amendment 

39–18551; AD 2016–12–02] 

RIN 2120–AA64 

Airworthiness Directives; Various 

Aircraft Equipped With BRPPowertrain GmbH & Co KG 912 A 

Series Engine 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: We are adopting a new 

airworthiness directive (AD) for various 

aircraft equipped with a BRP-Powertrain 

GmbH & Co KG (formerly Rotax Aircraft 

Engines) 912 A series engine. This AD 

results from mandatory continuing 

airworthiness information (MCAI) 

issued by an aviation authority of 

another country to identify and correct 

an unsafe condition on an aviation 

product. The MCAI describes the unsafe 

condition as a design change of the 

engine cylinder head temperature 

sensor without a concurrent revision of 

the engine model designation, the 

engine part number, or the cockpit 

indication to the pilot. We are issuing 

this AD to require actions to address the 

unsafe condition on these products. 

DATES: This AD is effective July 15, 

2016. 

The Director of the Federal Register 

approved the incorporation by reference 

of a certain publication listed in the AD 

as of July 15, 2016. 

ADDRESSES: You may examine the AD 

docket on the Internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2016– 

4878; or in person at Document 

Management Facility, U.S. Department 

of Transportation, Docket Operations, 

M–30, West Building Ground Floor, 


asabaliauskas on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Rules and Regulations 37497 

Room W12–140, 1200 New Jersey 

Avenue SE., Washington, DC 20590. 

For service information identified in 

this AD, contact BRP-Powertrain GmbH 

& Co. KG, Welser Strasse 32, A–4623 

Gunskirchen, Austria; phone: +43 7246 

601 0; fax: +43 7246 601 9130; Internet: 

www.rotax-aircraft-engines.com. You 

may view this referenced service 

information at the FAA, Small Airplane 

Directorate, 901 Locust, Kansas City, 

Missouri 64106. For information on the 

availability of this material at the FAA, 

call (816) 329–4148. It is also available 

on the Internet at http://

www.regulations.gov by searching for 

Docket No. FAA–2016–4878. 

FOR FURTHER INFORMATION CONTACT: Jim 

Rutherford, Aerospace Engineer, FAA, 

Small Airplane Directorate, 901 Locust, 

Room 301, Kansas City, Missouri 64106; 

telephone: (816) 329–4165; fax: (816) 

329–4090; email: jim.rutherford@

faa.gov. 

SUPPLEMENTARY INFORMATION: 

Discussion 

We issued a notice of proposed 

rulemaking (NPRM) to amend 14 CFR 

part 39 by adding an AD that would 

apply to various aircraft equipped with 

a BRP-Powertrain GmbH & Co KG 

(formerly Rotax Aircraft Engines) 912 A 

series engine. The NPRM was published 

in the Federal Register on March 28, 

2016 (81 FR 17109). The NPRM 

proposed to correct an unsafe condition 

for the specified products and was 

based on mandatory continuing 

airworthiness information (MCAI) 

originated by an aviation authority of 

another country. The MCAI states: 

A design change of the engine cylinder 

heads was introduced by BRP-Powertrain in 

March 2013 which modifies the engine/

aircraft interfaces by substituting the 

previous cylinder head temperature (CHT) 

measurement (limit temperature 135 °C/150 

°C) with a coolant temperature (CT) 

measurement (limit temperature 120 °C). The 

design change was communicated on 15 May 

2013 by BRP-Powertrain Service Instruction 

(SI) 912–020R7/914–022R7 (single 

document) but was not identified by a change 

of the engine model designation or of the 

engine P/N, but only through the cylinder 

head P/N and the position of the temperature 

sensor. 

Consequently, engines with the new 

cylinder heads (installed during production 

or replaced in-service during maintenance) 

may be installed on an aircraft without 

concurrent modification of that aircraft, 

instructions for which should be provided by 

the Type Certificate (TC) holder or 

Supplemental Type Certificate (STC) holder, 

as applicable. In this case, the coolant 

temperature with a maximum engine 

operating limit of 120 °C (valid for engines 

operated with water diluted glycol coolant) is 

displayed on a CHT indicator with a typical 

limit marking (red radial/range) of more than 

120 °C. 

This condition, if not detected and 

corrected, will prevent the pilot to identify 

coolant limit exceedances, with subsequent 

loss of coolant (120 °C is the boiling 

temperature of the coolant), which could lead 

to engine in-flight shut-down, possibly 

resulting in a forced landing, with 

consequent damage to the aircraft and injury 

to occupants. 

BRP-Powertrain published revised SI–912– 

020R8/914–022R8 to clarify that, on the new 

cylinder heads, the coolant temperature, 

instead of the cylinder head temperature in 

the aluminum, is measured. EASA issued SIB 

2014–34 to raise awareness that installation 

of affected engines and spare parts, without 

concurrent incorporation of aircraft TC/STC 

holder approved modifications, and even if 

unintended and unnoticed by production or 

maintenance, constitutes an unapproved 

aircraft modification. 

Since EASA published the SIB, further 

investigation has finally determined that 

sufficient reason exists to warrant AD action. 

For the reason stated above, this AD 

requires a one-time inspection to determine 

the actual engine configuration and, 

depending on findings, engine 

reidentification and (depending on TC or 

STC holder installation) modification of the 

affected aircraft. This also affects engines that 

are operated with waterless coolant. 

The MCAI can be found in the AD 

docket on the Internet at https://

www.regulations.gov/

#!documentDetail;D=FAA-2016-4878- 

0002. 

Comments 

We gave the public the opportunity to 

participate in developing this AD. We 

received no comments on the NPRM (81 

FR 17109, March 28, 2016) or on the 

determination of the cost to the public. 

Conclusion 

We reviewed the relevant data and 

determined that air safety and the 

public interest require adopting the AD 

as proposed except for minor editorial 

changes. We have determined that these 

minor changes: 

• Are consistent with the intent that 

was proposed in the NPRM (81 FR 

17109, March 28, 2016) for correcting 

the unsafe condition; and 

• Do not add any additional burden 

upon the public than was already 

proposed in the NPRM (81 FR 17109, 

March 28, 2016). 

Related Service Information Under 1 

CFR Part 51 

We reviewed BRP-Powertrain GmbH 

& CO KG issued Rotax Aircraft Engines 

BRP Service Bulletin SB–912–068 and 

SB–914–049 (co-published as one 

document), dated April 16, 2015. The 

service information describes 

procedures for re-identifying the engine 

that has new cylinder heads, part 

numbers 413235 and 413236 installed. 

This service information is reasonably 

available because the interested parties 

have access to it through their normal 

course of business or by the means 

identified in the ADDRESSES section of 

the AD. 

Costs of Compliance 

We estimate that this AD will affect 

65 products of U.S. registry. 

We also estimate that it will take 

about 1 work-hour per product to 

comply with the engine re-identification 

requirement of this AD. The average 

labor rate is $85 per work-hour. 

Based on these figures, we estimate 

the cost of this portion of this AD on 

U.S. operators to be $5,525, or $85 per 

product. 

We also estimate that it will take 

about 1 work-hour per product to 

comply with the engine installation 

modification to indicate a Maximum 

Coolant Temperature requirement of 

this AD. The average labor rate is $85 

per work-hour. 

Based on these figures, we estimate 

the cost of this portion of this AD on 

U.S. operators to be $5,525, or $85 per 

product. 

We also estimate that it will take 

about 1.5 work-hours per product to 

comply with the cylinder head 

replacement option of this AD. The 

average labor rate is $85 per work-hour. 

Required parts will cost about $2,500 to 

replace a single engine cylinder head. 

Based on these figures, we estimate 

the cost of this portion of this AD on 

U.S. operators to be $2,627.50 per 

engine cylinder head. 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

section 106, describes the authority of 

the FAA Administrator. ‘‘Subtitle VII: 

Aviation Programs,’’ describes in more 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in ‘‘Subtitle VII, 

Part A, Subpart III, section 44701: 

General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 


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37498 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Rules and Regulations 

Regulatory Findings 

We determined that this AD will not 

have federalism implications under 

Executive Order 13132. This AD will 

not have a substantial direct effect on 

the States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government. 

For the reasons discussed above, I 

certify this AD: 

(1) Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866, 

(2) Is not a ‘‘significant rule’’ under 

the DOT Regulatory Policies and 

Procedures (44 FR 11034, February 26, 

1979), 

(3) Will not affect intrastate aviation 

in Alaska, and 

(4) Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

Adoption of the Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA amends 14 CFR part 39 as 

follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new AD: 

2016–12–02 Various Aircraft: Amendment 

39–18551; Docket No. FAA–2016–4878; 

Directorate Identifier 2016–CE–001–AD. 

(a) Effective Date 

This airworthiness directive (AD) becomes 

effective July 15, 2016. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to all serial numbers of the 

airplanes listed in table 1 of paragraph (c) of 

this AD, that are: 

(1) equipped with a BRP-Powertrain GmbH 

& Co KG (formerly Rotax Aircraft Engines) 

912 A series engine with a part number (P/ 

N) 413235 or 413236 cylinder head installed 

in position 2 or 3; and 

(2) certificated in any category. 

TABLE 1 OF PARAGRAPH (c)—AFFECTED AIRPLANES

Type certificate holder Aircraft model Engine model 

Aeromot-Indu ́stria Mecaˆnico-Metalu ́rgica Ltda ........................... AMT–200 ................................................................................... 912 A2 

Diamond Aircraft Industries ........................................................ HK 36 R ‘‘SUPER DIMONA’’ .................................................... 912 A 

DIAMOND AIRCRAFT INDUSTRIES GmbH ............................. HK 36 TS and HK 36 TC .......................................................... 912 A3 

Diamond Aircraft Industries Inc. ................................................. DA20–A1 ................................................................................... 912 A3 

HOAC-Austria ............................................................................. DV 20 KATANA ......................................................................... 912 A3 

Iniziative Industriali Italiane S.p.A. .............................................. Sky Arrow 650 TC ..................................................................... 912 A2 

SCHEIBE-Flugzeugbau GmbH ................................................... SF 25C ...................................................................................... 912 A2, 912 A3 

(d) Subject 

Air Transport Association of America 

(ATA) Code 72: Engine—Reciprocating. 

(e) Reason 

This AD results from mandatory 

continuing airworthiness information (MCAI) 

issued by an aviation authority of another 

country to identify and correct an unsafe 

condition on an aviation product. This AD 

was prompted by design change of the engine 

cylinder head temperature sensor without a 

concurrent revision of the engine model 

designation, the engine part number, or the 

cockpit indication to the pilot. The sensor 

now measures the coolant temperature rather 

than the cylinder head temperature. If the 

engine coolant temperature with a maximum 

engine operating limit of 120 °C is displayed 

on a Cylinder Head Temperature indicator 

with a typical limit marking greater than 120 

°C, the pilot will be unable to identify 

coolant temperature limit exceedances. This 

could result in loss of coolant, which could 

cause an inflight engine shutdown and forced 

landing. 

(f) Actions and Compliance 

Unless already done, do the following 

actions: 

(1) Within 6 months after July 15, 2016 (the 

effective date of this AD), for engines with 

cylinder heads listed in paragraph (c)(1) of 

this AD installed on both position 2 and 

position 3, change the engine model 

designation on the engine type data plate to 

include a ‘‘–01’’ suffix following paragraph 

3.1.1) of the Accomplishment/Instructions in 

Rotax Aircraft Engines BRP Service Bulletin 

SB–912–068 and SB–914–049 (co-published 

as one document), dated April 16, 2015. 

(2) Within 6 months after July 15, 2016 (the 

effective date of this AD), for engines with 

only one cylinder head listed paragraph (c)(1) 

of this AD installed in a position 2 or 3, in 

order to keep such cylinder installed, you 

must replace the cylinder head installed on 

the unchanged position (2 or 3, as applicable) 

with a cylinder head having a P/N listed in 

paragraph (c)(1) of this AD, and change the 

engine model designation on the engine type 

data plate to include a ‘‘–01’’ suffix following 

paragraph 3.1.1) of the Accomplishment/

Instructions in Rotax Aircraft Engines BRP 

Service Bulletin SB–912–068 and SB–914– 

049 (co-published as one document), dated 

April 16, 2015. 

(3) Before further flight after doing the 

required actions in paragraphs (f)(1) or (f)(2) 

of this AD as applicable, modify the aircraft 

and related documentation to indicate a 

Maximum Coolant Temperature limit of 120 

°C using FAA-approved procedures. 

(i) Such procedures can be found by 

contacting your aircraft type certificate 

holder or the FAA contact specified in 

paragraph (g)(1) of this AD. The service 

documents referenced in paragraph (h) of this 

AD are examples of FAA-approved 

procedures for the applicable aircraft. 

(ii) These re-identified engines remain 

eligible for installation on approved aircraftengine combinations. 

(4) As of July 15, 2016 (the effective date 

of this AD), do not install any other P/N 

cylinder head unless that installation is done 

following approved instructions provided by 

BRP-Powertrain at the address provided in 

paragraph (i)(3) of this AD. 

(g) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, Standards Office, 

FAA, has the authority to approve AMOCs 

for this AD, if requested using the procedures 

found in 14 CFR 39.19. Send information to 

ATTN: Jim Rutherford, Aerospace Engineer, 

FAA, Small Airplane Directorate, 901 Locust, 

Room 301, Kansas City, Missouri 64106; 

telephone: (816) 329–4165; fax: (816) 329– 

4090; email: jim.rutherford@faa.gov. Before 

using any approved AMOC on any airplane 

to which the AMOC applies, notify your 

appropriate principal inspector (PI) in the 

FAA Flight Standards District Office (FSDO), 

or lacking a PI, your local FSDO. 

(2) Airworthy Product: For any requirement 

in this AD to obtain corrective actions from 

a manufacturer or other source, use these 

actions if they are FAA-approved. Corrective 

actions are considered FAA-approved if they 

are approved by the State of Design Authority 

(or their delegated agent). You are required 

to assure the product is airworthy before it 

is returned to service. 


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(h) Related Information 

Refer to MCAI European Aviation Safety 

Agency (EASA) AD No.: 2015–0240, dated 

December 18, 2015; Rotax Aircraft Engines 

BRP Service Bulletin SB–912–066 R1/SB– 

914–047 R1 (published as one document), 

Revision 1, dated April 23, 2015; Diamond 

Aircraft Industries GmbH Optional Service 

Bulletin OSB 36–111, dated September 17, 

2015; Diamond Aircraft Industries GmbH 

Work Instruction WI–OSB 36–111, dated 

September 17, 2015; Diamond Aircraft 

Service Bulletin No.: DA20–72–04, dated 

January 22, 2015; Diamond Aircraft 

Industries GmbH Optional Service Bulletin 

OSB 20–066, dated September 17, 2015; 

Diamond Aircraft Industries GmbH Work 

Instruction WI–OSB 20–066, dated 

September 17, 2015; and Scheibe Aircraft 

GmbH Service Information 02/14–1, dated 

December 15, 2014, for related information. 

You may examine the MCAI on the Internet 

at https://www.regulations.gov/

#!documentDetail;D=FAA-2016-4878-0002. 

For information on the availability of the 

service documents above, contact the FAA, 

Small Airplane Directorate, at 816–329–4148. 

(i) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless the AD specifies otherwise. 

(i) Rotax Aircraft Engines BRP Service 

Bulletin SB–912–068 and SB–914–049 (copublished as one document), dated April 16, 

2015. 

(ii) Reserved. 

(3) For BRP-Powertrain GmbH & CO KG 

service information identified in this AD, 

contact BRP-Powertrain GmbH & Co. KG, 

Welser Strasse 32, A–4623 Gunskirchen, 

Austria; phone: +43 7246 601 0; fax: +43 

7246 601 9130; Internet: www.rotax-aircraftengines.com. 

(4) You may view this service information 

at the FAA, Small Airplane Directorate, 901 

Locust, Kansas City, Missouri 64106. For 

information on the availability of this 

material at the FAA, call (816) 329–4148. In 

addition, you can access this service 

information on the Internet at http://

www.regulations.gov by searching for and 

locating Docket No. FAA–2016–4878. 

(5) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, call 

202–741–6030, or go to: http://

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued in Kansas City, Missouri, on June 1, 

2016. 

Pat Mullen, 

Acting Manager, Small Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2016–13542 Filed 6–9–16; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 886 

[Docket No. FDA–2016–N–1308] 

Medical Devices; Ophthalmic Devices; 

Classification of Nasolacrimal 

Compression Device 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

nasolacrimal compression device into 

class I (general controls). The Agency is 

classifying the device into class I 

(general controls) in order to provide a 

reasonable assurance of safety and 

effectiveness of the device. 

DATES: This order is effective June 10, 

2016. The classification was applicable 

on April 20, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Fedorko, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2414, Silver Spring, 

MD 20993–0002, 301–796–6620. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 

360c(f)(1)), devices that were not in 

commercial distribution before May 28, 

1976 (the date of enactment of the 

Medical Device Amendments of 1976), 

generally referred to as postamendments 

devices, are classified automatically by 

statute into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or reclassified 

into class I or II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the FD&C Act, to a predicate 

device that does not require premarket 

approval. The Agency determines 

whether new devices are substantially 

equivalent to predicate devices by 

means of premarket notification 

procedures in section 510(k) of the 

FD&C Act (21 U.S.C. 360(k)) and part 

807 (21 CFR part 807) of the regulations. 

Section 513(f)(2) of the FD&C Act, as 

amended by section 607 of the Food and 

Drug Administration Safety and 

Innovation Act (Pub. L. 112–144), 

provides two procedures by which a 

person may request FDA to classify a 

device under the criteria set forth in 

section 513(a)(1) of the FD&C Act. 

Under the first procedure, the person 

submits a premarket notification under 

section 510(k) of the FD&C Act for a 

device that has not previously been 

classified and, within 30 days of 

receiving an order classifying the device 

into class III under section 513(f)(1) of 

the FD&C Act, the person requests a 

classification under section 513(f)(2). 

Under the second procedure, rather than 

first submitting a premarket notification 

under section 510(k) of the FD&C Act 

and then a request for classification 

under the first procedure, the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence and requests a classification 

under section 513(f)(2) of the FD&C Act. 

If the person submits a request to 

classify the device under this second 

procedure, FDA may decline to 

undertake the classification request if 

FDA identifies a legally marketed device 

that could provide a reasonable basis for 

review of substantial equivalence with 

the device or if FDA determines that the 

device submitted is not of ‘‘lowmoderate risk’’ or that general controls 

would be inadequate to control the risks 

and special controls to mitigate the risks 

cannot be developed. 

In response to a request to classify a 

device under either procedure provided 

by section 513(f)(2) of the FD&C Act, 

FDA will classify the device by written 

order within 120 days. This 

classification will be the initial 

classification of the device. 

On June 27, 2014, Innovatex, Inc., 

submitted a request for classification of 

the Tear Duct Occluder (originally 

referred to as the Glaucoma Companion 

Nasolacrimal Compression Device) 

under section 513(f)(2) of the FD&C Act. 

The manufacturer recommended that 

the device be classified into class I (Ref. 

1). 

In accordance with section 513(f)(2) of 

the FD&C Act, FDA reviewed the 

request in order to classify the device 

under the criteria for classification set 

forth in section 513(a)(1) of the FD&C 

Act. FDA classifies devices into class I 

if general controls by themselves are 

sufficient to provide reasonable 

assurance of safety and effectiveness of 

the device for its intended use. After 

review of the information submitted in 

the de novo request, FDA determined 

that the device can be classified into 

class I. FDA believes general controls 

will provide reasonable assurance of the 

safety and effectiveness of the device. 

Therefore, on April 20, 2016, FDA 

issued an order to the requestor 

classifying the device into class I. FDA 


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